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The allowance for investigators to use all available information (for example, concomitant medication) to assess glycemic category was primarily included to account for scenarios in which glucose-lowering medications were initiated during the trial that would confound glycemic category assessment if based purely on fasting plasma glucose or HbA 1c levels (for example, if a patient developed diabetes during the study and received a glucose-lowering drug that resulted in their glucose level being below the American Diabetes Association threshold for type 2 diabetes diagnosis)

However, the IM route was the top-ranked statistically but without clinical significance